Colorectal Cancer
Conditions
Interventions
Cetuximab 500mg/m2/bi-week(day1) Oxaliplatin 85mg/m2/bi-week(day1) l-LV 200 mg/m2/bi-week(day1) 5-FU/bolus 400mg/m2/bi-week bolus(day1) 5-FU/infusional 2400mg/m2/bi-week(day1-3) Cetuximab 500mg
Sponsors
Epidemiological and Clinical research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with histologically proven colorectal cancer (2)EGFR expression is confirmed by immunohistochemical evaluation (3)KRAS wild type in codon 12, 13, 61 and BRAF wild type in V600E (4) Metastatic and/or recurrent disease and no prior chemotherapies. Prior Oxaliplatin adjuvant therapy is allowed if it is completed at least 24 weeks before registration. (5)Age 20 years<= (6)ECOG performance status 0-1 (7)Presence of at least one measurable lesion (according to the RECIST) (8)Patiens have enough organ function for study treatment (9)Life expectancy of more than 3 months (10)Written informed consent
Exclusion criteria
Exclusion criteria: (1)Severe bone marrow suppression (2)Severe infectious disease (3) Severe dysesthesia or sensory abnormality with functional disorder (4) History of psychiatric disorder, central nervous system disorder or cerebrovascular accident (5)Comorbidity or history of heart failure (6)Comorbidity or history of interstitial lung disease or pulmonary fibrosis (7) Radiotherapy to target lesion ( Perioperative Adjuvant Radiotherapy is eligible ) (8)History of severe allergy (9)Pregnant or lactating women or women of childbearing potential (10)Severe comorbidity (renal insufficiency, hepatic failure, hypertension, hypercalcemia etc) (11)Symptomatic brain metastasis (12)Simultaneous or metachronous double cancers (13)Any other cases who are regarded as inadequate for study enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Overall survival, Disease control rate, Safety profile, Dose intensity, Conversion rate of nonresectable liver metastases to resectable | — |
Countries
Japan
Contacts
Public ContactMai Hatta
Young Leaders&#39; Program (YLP), Nagoya University School of Medicine See Above
Outcome results
None listed